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Informationscenter zur EU-Medizinprodukteverordnung (MDR)
Hier finden Sie einige wichtige Dokumente, die Sie bei Ihrem Antrag auf Zertifizierung gemäß der Medizinprodukteverordnung (MDR) unterstützen.
Referenzen:
MDR Unannounced Audit Questionnaire
pdf
0.15
Medical Device Questionnaire
pdf
0.24
Medical Device Regulation (MDR) Conformity Assessment Explained
pdf
0.3
Medical Device Regulation (MDR) Readiness Checklist
pdf
0.35
Medical Device Regulation (MDR) Technical Documentation Request Form
pdf
0.39
Medical Devices Notification of Changes, Regulatory Action, Consultancy or Services Rendered
pdf
2.43
Medical Devices Pre-Audit Client Questionnaire
pdf
0.62
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Externe Links
EUDAMED - Actor Registration Factsheet
pdf
1.31
Factsheet for Manufacturers of In Vitro Diagnostic Medical Devices
pdf
0.34
Factsheet for Manufacturers of Medical Devices
pdf
0.32
Factsheet - Medical Devices and in vitro Diagnostic Medical Devices (For Authorised Representatives, Importers and Distributors)
pdf
0.32
Factsheet on Medical Devices and in vitro Diagnostic Medical Devices (For non-EU/EEA States)
pdf
0.33
Guidance for Actor Registration Module in EUDAMED (V1 -Sept. 2020)
pdf
2.81
Implementation for Medical Devices Regulation (Focus on Manufacturer’s obligations)
pdf
0.6
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Kontakt
E-Mail senden
SGS / SGS INSTITUT FRESENIUS / SGS-TÜV Saar – Germany – Hamburg
+49 40 30101 0
Heidenkampsweg 99,
20097, Hamburg, Deutschland
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Notified Body Managers' Declaration of Interest
pdf
0.48
SGS MDR Transition Plan Template
pdf
0.18
Product Medical Device Questionnaire
pdf
0.78
Public Prices
pdf
0.19
Relevant Subcontractors and Suppliers List
pdf
0.23
Transition Guidance for SGS Customers
pdf
0.42
Implementation Model for In-Vitro Diagnostic Medical Devices Regulation
pdf
0.1
Implementation Model for Medical Devices Regulation
pdf
0.1
MDR IVDR Infographic
pdf
0.54
Transition Timelines from the Directives to the Regulations
pdf
0.53